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Moderna’s COVID-19 Vaccine Grabs Fast-Track Designation from FDA

May 13, 2020

The FDA has granted Moderna’s COVID-19 vaccine candidate a fast-track designation, making it the first potential vaccine to receive the agency’s expedited review status.

The company is finalizing the protocol for a phase 3 study of the vaccine, mRNA-1273. The phase 3 trial is expected to begin in early summer.

Moderna previously received fast-track designations for three other messenger RNA vaccine programs, including its investigational Zika vaccine.

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